Medical Devices Quality Management Systems
QM 010
TUV Rheinland (India) Pvt. Ltd.
Address 27/B, 2nd Cross Road, Electronics City, Phase- 1, Bangalore - 560 100, India
Contact Person Mr. M.Bhaskar Mr. Dayanand K R
Designation Director, Finance and General Administration Assistant General Manager
Tel + 91 80 3055 4345 +91-80-46498031
Fax +91 80 3055 4342 +91-80-46498042
Email ID info-ind@ind.tuv.com, dayanand.kr@ind.tuv.com
Website www.ind.tuv.com
Valid From 31 July 2017
Valid Upto 15 August 2027
Accreditation Standard ISO/IEC 17021-1:2015 and IAF MD 9
 
Scopes of accreditation
ISO 13485 - Medical Devices Quality Management Systems
Main Technical Areas (as per IAF MD 8) Description (Main Technical Areas) Technical Areas
A1.1 Non-Active Medical Devices General non-active, non-implantable medical devices
Non-active implants
Devices for wound care
Non-active dental devices and accessories
Non-active medical devices other than specified above
A1.2 Active Medical Devices (Non-Implantable) General active medical devices
Devices for imaging
Monitoring devices
Devices for radiation therapy and thermo therapy
Active (non-implantable) medical devices other than specified above
A1.5 Sterilization Methods for Medical Devices Ethylene oxide gas sterilization (EOG)
Moist heat
Aseptic processing
Radiation sterilization (e.g. gamma, x-ray, electron beam)
Sterilization method other than specified above
A1.7 Parts or services (restricted to the Parts or Services of those Scopes which are accredited under MTA 1.1, 1.2, 1.5) Raw Materials
Components
Sub Assemblies
Calibration Services
Distribution Services
Transportation Services
Other Services
 
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